Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415058
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-16
First Post:
2024-05-01
Brief Title:
Study to Investigate Blood Samples Drawn With the HemoIV System
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
A Prospective Nonrandomized Controlled Clinical Investigation of Blood Samples Drawn With the HEMOIV System During Continuous IV Flow
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to compare blood drawn using a device called HemoIV to standard-of-care blood drawn from a vein in the arm or from an IV catheter The HemoIV is a device that is attached to an IV line This device allows for blood to be drawn while a patient is receiving IV fluids
The main questions it aims to answer are
Will the HemoIV device allow blood to be drawn without having to stop IV fluids
Will the HemoIV device provide the same laboratory results as blood draws done by current standard practice
Participants will
Receive standard medical procedures andor treatment
Have a HemoIV device inserted into their IV line in one arm
Have an blood drawn twice from the HemoIV and from an IV line or needle stick from a vein in the other arm The second blood draw will be done about 8-22 hours after the first blood draw
Have the device removed after the second blood draw
Receive a phone call about 8 days later to see how you are doing
The main questions it aims to answer are
Will the HemoIV device allow blood to be drawn without having to stop IV fluids
Will the HemoIV device provide the same laboratory results as blood draws done by current standard practice
Participants will
Receive standard medical procedures andor treatment
Have a HemoIV device inserted into their IV line in one arm
Have an blood drawn twice from the HemoIV and from an IV line or needle stick from a vein in the other arm The second blood draw will be done about 8-22 hours after the first blood draw
Have the device removed after the second blood draw
Receive a phone call about 8 days later to see how you are doing
Detailed Description:
The HemoIV investigational device allows for continuous administration of intravenous fluids for blood draw sampling without exposing patients to additional needle sticks stoppage of intravenous therapy and potential exposure to bacteria that are inherent risks when performing blood draws using traditional phlebotomy methods The purpose of this study is to demonstrate the safety and effectiveness of the HemoIV system
Participants serve as their own control to compare blood measurement parameters Blood measurements extracted from the participant will be used to compare the control blood samples to the HemoIV blood samples The contralateral arm to the placement of the HemoIV will be the control arm of the study It is hypothesized that the HemoIV will provide blood samples within the equivalency margin compared to standard practice Venipuncture or Peripheral IV Catheter
The main objectives are
To quantitatively measure and compare blood samples drawn with the HemoIV system during continuous intravenous infusion to blood samples from the contralateral arm to demonstrate safety and efficacy of the HemoIV system
To quantitatively measure and compare the potential advantages of HemoIV to Venipuncture or Peripheral IV Catheter blood draws
Participant population will consist of adult patients admitted to the hospital for a medical condition in the emergency department inpatient or observation units and are requiring blood draws as well as intravenous fluids
Participants will
Receive standard of care intravenous therapy via HemoIV inserted through an established peripheral IV catheter
Have blood samples obtained twice over a 24 hour period from the HemoIV and from an IV line or standard venipuncture from the contralateral arm
The second blood sampling will occur approximately 8-22 hours after the first blood sampling
The HemoIV device will be removed one hour after the second blood sampling occurs
Participants will be called 8 days later to assess for adverse events
Quality control QC procedures will be implemented beginning with the data entry system and data QC checks that will be run on the database will be generated Any missing data or data anomalies will be communicated to the sites for clarificationresolution
Participants serve as their own control to compare blood measurement parameters Blood measurements extracted from the participant will be used to compare the control blood samples to the HemoIV blood samples The contralateral arm to the placement of the HemoIV will be the control arm of the study It is hypothesized that the HemoIV will provide blood samples within the equivalency margin compared to standard practice Venipuncture or Peripheral IV Catheter
The main objectives are
To quantitatively measure and compare blood samples drawn with the HemoIV system during continuous intravenous infusion to blood samples from the contralateral arm to demonstrate safety and efficacy of the HemoIV system
To quantitatively measure and compare the potential advantages of HemoIV to Venipuncture or Peripheral IV Catheter blood draws
Participant population will consist of adult patients admitted to the hospital for a medical condition in the emergency department inpatient or observation units and are requiring blood draws as well as intravenous fluids
Participants will
Receive standard of care intravenous therapy via HemoIV inserted through an established peripheral IV catheter
Have blood samples obtained twice over a 24 hour period from the HemoIV and from an IV line or standard venipuncture from the contralateral arm
The second blood sampling will occur approximately 8-22 hours after the first blood sampling
The HemoIV device will be removed one hour after the second blood sampling occurs
Participants will be called 8 days later to assess for adverse events
Quality control QC procedures will be implemented beginning with the data entry system and data QC checks that will be run on the database will be generated Any missing data or data anomalies will be communicated to the sites for clarificationresolution
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None